Oversubscribed financing led by strategic
investor, with participation from new and existing
investors
MINNEAPOLIS, June 25,
2024 /PRNewswire/ -- Endogenex, a clinical-stage
medical device company dedicated to improving outcomes in
individuals with type 2 diabetes, announced it has closed an
oversubscribed Series C financing totaling $88 million. The new capital will be used to
complete the pivotal ReCET Clinical Study, which has been granted
an Investigational Device Exemption (IDE) by the U.S. Food and Drug
Administration (FDA). A group of new investors, including Hatteras
Venture Partners, Lumira Ventures, and Orlando Health Ventures,
joined an undisclosed strategic lead investor and existing
investors Intuitive Ventures, Longitude Capital, Mayo Clinic, and
Santé Ventures in the Series C funding.
"We are excited to take this significant step forward in our
mission to transform diabetes care," said Stacey Pugh, CEO of Endogenex. "This funding
will enable us to complete our pivotal clinical study, bringing us
closer to offering a groundbreaking solution for type 2 diabetes
patients. The therapeutic landscape in diabetes continues to
evolve, especially around the earlier use of SGLT2i and GLP-1RA.
However, there remains a considerable unmet need to address the
underlying pathophysiology and progression of the disease."
"We are very proud of the company's progress, and this
successful funding round is a testament to Endogenex's innovative
technology," said Juliet Tammenoms Bakker, Endogenex Board Chair
and Managing Director at Longitude Capital. "This milestone
underscores our investors' confidence in the company's vision and
the impact it can make in treating the epidemic of type 2 diabetes
around the world."
About the ReCET Clinical Study
The ReCET Clinical
Study is a multicenter, prospective, randomized, double-blinded,
sham-controlled study assessing the safety and effectiveness of the
ReCET System. The pivotal study received IDE approval in
November 2023. The study will enroll
up to 350 patients at clinical sites in the United States and Australia.
About the ReCET™ Procedure
ReCET is a novel,
endoscopic outpatient procedure that targets the cellular pathology
of the duodenum. This pathology may contribute to the development
and progression of type 2 diabetes.
The ReCET System aims to initiate the body's natural
regenerative process by applying highly controlled, non-thermal
pulsed electric fields to the mucosa and sub-mucosa duodenal
tissue. This approach may help restore proper cellular signaling
from the duodenum and improve metabolic function, including better
control of blood glucose levels.
The ReCET System has been evaluated in feasibility clinical
studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the
safety and efficacy of the treatment in adults with type 2 diabetes
whose blood glucose levels were inadequately controlled despite
using insulin and non-insulin medications. Preliminary outcomes
from these studies have been presented at medical conferences
globally.
The ReCET System has received an FDA Breakthrough Device
Designation for treating type 2 diabetes in adults inadequately
controlled by glucose-lowering medications.
About Endogenex™
Endogenex, founded in partnership
with Mayo Clinic, aims to revolutionize treatment options for
individuals with type 2 diabetes (T2D). The company's innovations
focus on resetting the body's metabolic signaling system by
harnessing its natural regenerative capabilities to improve
metabolic function. Through the development of the ReCET System and
the novel application of precise, controlled, non-thermal pulsed
electric fields, Endogenex is establishing a new era in T2D
therapy, helping patients regain control of their blood glucose
levels and slow disease progression.
For more information, please visit www.endogenex.com.
Media Inquiries:
Brent Collins
bcollins@endogenex.com
+1(612) 227-6949
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SOURCE Endogenex